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FDA Grants Breakthrough Device Designation to Cleerly®'s Heart Disease Risk Staging System

Cleerly, a company committed to revolutionizing heart disease diagnosis, has earned Breakthrough Device Designation from the FDA for its Coronary Artery Disease (CAD) Staging System. This innovative software, which utilizes noninvasive imaging techniques, offers detailed analysis of coronary atherosclerosis, stenosis, and ischemia. By providing enhanced risk assessment capabilities, it aims to assist physicians in identifying patients at risk of major adverse cardiovascular events (MACE), such as heart attacks, before they occur.

The FDA's Breakthrough Device Designation recognizes the potential of Cleerly's CAD Staging System to significantly improve the diagnosis and treatment of life-threatening diseases. This designation expedites the regulatory process, ensuring timely availability of innovative technologies. Additionally, Cleerly's CAD Staging System has been selected for the FDA's Total Product Life Cycle Advisory Program (TAP) Pilot, a program aimed at facilitating rapid access to breakthrough medical devices for patients and healthcare providers.

The Cleerly CAD Staging System will undergo further validation through the TRANSFORM randomized controlled trial, focusing on asymptomatic individuals with diabetes, pre-diabetes, or metabolic syndrome. Presently, risk assessment for future MACE relies primarily on risk factors rather than direct diagnosis of CAD, the leading cause of most heart attacks. By offering personalized risk assessment, Cleerly's CAD Staging System aims to revolutionize preventive CAD treatment, allowing for tailored therapy goals based on individualized risk profiles.

As Cleerly's CAD Staging System progresses towards availability, it represents a significant advancement in personalized cardiovascular care, empowering physicians and patients with the tools to proactively manage heart disease risk.


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